FDA Registration
Active
🇺🇸 United States
prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented
Reg #: 1529009
·
FEI: 1000149660
·
Expires 2025
Products
5
Proprietary Names
5
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- APS MATERIALS, INC.
- Registration Number
- 1529009
- FEI Number
- 1000149660
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4011 RIVERSIDE DR.
- City
- DAYTON
- State
- OH
- ZIP
- 45405
- Country
- US
Regulatory Submissions
- 510(k) Number
- K130390
Owner / Operator
- Firm Name
- APS Materials, Inc
- Operator Number
- 9023611
- Address
- 4011 Riverside Dr, Dayton OH
- City
- Dayton
- State
- OH
- Postal Code
- 45405
- Country
- US
- Correspondent
- Chris Page
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2019-07-16 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2019-07-16 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2019-07-16 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2019-07-16 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2019-07-16 |
Proprietary Names
prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented
shoulder prosthesis, reverse configuration
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)